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A Randomized, Open-Label, Phase 2, Multicenter Safety and Exploratory Efficacy Study of Investigational anti-Influenza A Immune Plasma for the Treatment of Influenza A
This study is currently recruiting participants.
Summary | Eligibility | Citations | Contacts
Summary
Number |
10-I-0043 |
Sponsoring Institute |
National Institute of Allergy and Infectious Diseases (NIAID) |
Recruitment Detail |
Type: Participants currently recruited/enrolled |
Referral Letter Required |
No |
Population Exclusion(s) |
None |
Special Instructions |
Currently Not Provided |
Keywords |
Antiviral; |
Recruitment Keyword(s) |
Swine Flu; |
Condition(s) |
H1N1 Influenza; |
Investigational Drug(s) |
Anti-H1N1 Influenza A Immune Plasma |
Investigational Device(s) |
None |
Intervention(s) |
Drug: H1N1 Plasma |
Supporting Site |
|
- Influenza A/H1N1 2009 (commonly referred to as swine flu) is a novel influenza virus. Because of the high rates of infection and death in spite of treatment with current antivirials and the limited therapeutic options for influenza, additional treatments for H1N1 are warranted.
- One potential treatment is the use of hyper-immune plasma as immunotherapy. This plasma is collected from individuals who have high levels of antibodies in the bloodstream, because they either have had the disease or have been vaccinated against it. Researchers are interested in determining whether infusions of hyper-immune plasma are a safe and effective treatment for the H1N1 influenza.
Objectives:
- To assess the safety, effectiveness, and lab results of H1N1 plasma in subjects with H1N1 influenza.
Eligibility:
- Individuals of any age who have been hospitalized with influenza A/H1N1 2009 and are at risk for severe disease. This study may include children and pregnant women.
Design:
- Participants will provide brief medical history and have a physical examination, including blood samples to check H1N1 levels. Researchers will swab the nose and the back of the mouth to test for influenza.
- All participants will receive treatment for influenza with standard anti-influenza medications.
- Participants will receive either plasma containing high levels of antibody against the influenza virus in addition to standard of care, or standard of care alone. Individuals who receive plasma will have two doses, separated by a few hours.
- Participants will be evaluated 2, 4, 7, 14, and 28 days after receiving the study treatment. Those who are no longer in the hospital will need to return to the clinic for these visits. Researchers will perform a brief exam, ask questions about symptoms, and collect blood and nose/mouth swab samples as needed.
Eligibility
INCLUSION CRITERIA:
Screening Enrollment:
Subjects must meet all of the following criteria to be enrolled for randomization into the study:
1. Provide written informed consent before initiation of any study procedures.
2. Hospitalization for signs and symptoms of influenza (decision for hospitalization will be up to the individual treating clinician).
3. Study plasma available.
Randomization
Subjects must meet all of the following criteria to be randomized in the study:
1. Provide written informed consent before initiation of any study procedures.
2. Diagnosis of influenza A within 2 days prior to enrollment by the local assay including rapid antigen, direct fluorescent antibody (DFA), polymerase chain reaction (PCR), or culture, and may test for either influenza A or more specific influenza A/H1N1 2009
3. Hospitalization for signs and symptoms of influenza (decision for hospitalization will be up to the individual treating clinician).
4. Abnormal respiratory status defined as room air saturation of oxygen (SaO2) , less than 93% OR tachypnea documented at any point within 24 hours prior to randomization.
5. Agree to the storage of specimens and data.
6. ABO compatible study plasma with activity against locally circulating strains of influenza is available.
EXCLUSION CRITERIA:
Randomization
Subjects who meet any of the following criteria will be excluded from study participation:
1. Receipt of non-licensed treatment for influenza within the last 2 weeks (or plans to receive anytime during the study). Use, however, of licensed drugs at non-approved doses or for off-label indications, or use of drugs under an Emergency Use Authorization (EUA) is not exclusionary.
2. Symptoms or signs of the acute influenza-like illness have occurred for more than 7 days prior to enrollment.
3. History of severe allergic reaction to blood products (as judged by the investigator).
4. Medical conditions for which receipt of 500mL volume (or 8 mL/kg for pediatric patients) may be dangerous to the subject (e.g. decompensated congestive heart failure, congenital heart disease for children, etc).
5. Clinical suspicion that etiology of illness is primarily bacterial in origin.
Citations:
Contacts:
Principal Investigator |
Referral Contact |
For more information: |
| Richard T. Davey Jr., M.D. National Institute of Allergy and Infectious Diseases (NIAID) National Institutes of Health BG 10-CRC RM 4-1479 MSC 1460 10 CENTER DR BETHESDA MD 20892-1460 (301) 496-8029 rdavey@niaid.nih.gov |
Jocelyn Voell, R.N. National Institute of Allergy and Infectious Diseases (NIAID) National Institutes of Health Building 10 Room 8C406 10 Center Drive Bethesda, Maryland 20892 (301) 435-7913 jvoell@niaid.nih.gov |
Patient Recruitment and Public Liaison Office Building 61 10 Cloister Court Bethesda, Maryland 20892-4754 Toll Free: 1-800-411-1222 TTY: 301-594-9774 (local),1-866-411-1010 (toll free) Fax: 301-480-9793 prpl@mail.cc.nih.gov |
Clinical Trials Number:
NCT01052480
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